Ventilation assembly including respiratory device and mechanical ventilator

ABSTRACT

A ventilator adaptor for switching between ventilator devices while maintaining respiratory support to a patient is described. The ventilator adaptor has a first movable element with a first inlet and a second inlet, and a second movable element movably attached to the first movable element and with an outlet. The outlet has an inner diameter of 14.5-15.5 mm, preferably 15 mm, and the first inlet and the second inlet have an outer diameter of 14.5-15.5 mm, preferably 15 mm. The outlet is in fluid communication with the first inlet in a first position or with the second inlet in a second position by moving the second movable element relative to the first movable element thereby aligning the outlet with the first inlet or the second inlet. The outlet may be attached to an endotracheal tube in order to form a ventilation assembly.

BACKGROUND OF THE INVENTION Technical Field

The present invention relates to an adaptor for switching betweenventilation devices.

Description of the Related Art

Mechanical ventilation is a lifesaving intervention when indicated.Patients with diseases or conditions that lead to acute respiratoryfailure (ARF) should be connected to a mechanical ventilator by means ofa ventilator circuit, until the underlying cause of the ARF is treatedor eliminated.

In many cases where mechanical ventilation is required, one or more ofthe lung areas are collapsed (called lung derecruitment). To treat this,a lung recruitment maneuver is required where a relatively high pressure(30 to 60 cm H₂O, or 2.94 to 5.88 kPa) is applied to the lungs for acertain period of time through a closed Patient-Circuit-Ventilatorsystem.

One of the most important components of a ventilation management plan isto maintain a patient's lung recruitment, meaning that all lung segmentsare kept open and well aerated. Once the lung is recruited from acollapsed state, it is important to minimize significant ventilationinterruption and/or circuit disconnection that may lead to recollapse.Continual recruitment and derecruitment of the lungs may lead toconditions such as barotrauma, pneumothorax, and ventilation perfusionmismatch. Furthermore, disconnecting a ventilator circuit may increasethe risk of a patient contracting ventilator associated pneumonia (VAP),which has a high mortality rate of 20%-50%.

However, the ventilator circuit may need to be paused or disconnectedfor different reasons, such as making changes to the ventilator circuit,transferring patients to other departments in or outside a hospital,suctioning or cleaning a patient's airway, providing manualresuscitation, or replacing the mechanical ventilator.

In view of the foregoing, one objective of the present invention is toprovide a ventilator adaptor having movable elements with two inlets andan outlet, to enable changes to a ventilator circuit while maintaining apatient's lung recruitment in a closed ventilation system.

BRIEF SUMMARY OF THE INVENTION

According to a first aspect, the present disclosure relates to aventilator adaptor, comprising a first movable element having a firstinlet and a second inlet, and a second movable element movably attachedto the first movable element and having an outlet extending in agenerally opposite direction from the first movable element. The outlethas an inner diameter of 14.5-15.5 mm, or about 15 mm, and the firstinlet and the second inlet have an outer diameter of 14.5-15.5 mm, orabout 15 mm. The outlet is in fluid communication with the first inletin a first position or is in fluid communication with the second inletin a second position by moving the second movable element relative tothe first movable element thereby aligning the outlet with the firstinlet or the second inlet.

In one embodiment, the ventilator adaptor has a movable compression sealsandwiched between the first movable element and the second movableelement.

In one embodiment, a surface of the first movable element opposite thesecond movable element is substantially planar, parabolic, or concave,and a first central axis of the first inlet, a second central axis ofthe second inlet, or both forms an angle of 50°-80° with the surface.

In one embodiment, the first movable element is slidable relative to thesecond movable element to align the outlet with the first inlet in thefirst position or the second inlet in the second position.

In one embodiment, the first movable element is rotatable relative tothe second movable element to align the outlet with the first inlet inthe first position or the second inlet in the second position.

In a further embodiment, the first movable element and the secondmovable element are disc-shaped.

In one embodiment, the ventilator adaptor, which, other than the firstinlet, the second inlet, and the outlet, does not have an additionalinlet or outlet.

In one embodiment, the ventilator adaptor has a third inlet on the firstmovable element.

In one embodiment, an intermediary position of the outlet between thefirst position and the second position establishes fluid communicationsimultaneously among the first inlet, the second inlet, and the outlet.

In one embodiment, no intermediary position of the outlet between thefirst position and the second position establishes fluid communicationsimultaneously among the first inlet, the second inlet, and the outlet.

In one embodiment, the ventilator adaptor has a cap configured to coverthe first inlet, the second inlet, or both independently.

In a further embodiment, the cap comprises a tether attached to acrossbar connected to both the first inlet and the second inlet, whereinthe cap is configured to independently cover the first inlet or thesecond inlet.

In one embodiment, at least one selected from the group consisting ofthe first inlet, the second inlet, and the outlet comprises a rotatablejoint.

In one embodiment, a surface of the first movable element opposite thesecond movable element is substantially planar, and a section of thefirst inlet or the second inlet is angled or curved, so that a distaledge of the first inlet or the second inlet circumscribes a planeforming an angle of 60°-90° with the surface.

In one embodiment, the ventilator adaptor has a switch to lock the firstmovable element relative to the second movable element.

In one embodiment, the ventilator adaptor has a label, a notch, or agroove to indicate an alignment of the first movable element withrespect to the second movable element in the first position or in thesecond position.

According to a second aspect, the present disclosure relates to aventilation assembly comprising the ventilator adaptor of the firstaspect and an endotracheal tube removably attached to the outlet.

According to a third aspect, the present disclosure relates to a methodfor switching between ventilator devices with the ventilation assemblyof the second aspect, while respiratory support through the endotrachealtube is maintained. This method involves:

-   -   providing respiratory support by fluidly connecting the        endotracheal tube with a first ventilator device fluidly        connected to the first inlet, wherein the outlet is in the first        position;    -   connecting a second ventilator device to the second inlet;    -   moving the outlet from the first position to the second position        thereby providing respiratory support by fluidly connecting the        endotracheal tube with the second ventilator device; and    -   disconnecting the first ventilator device from the first inlet.

In one embodiment of the method, the first ventilator device is amechanical ventilator, and the second ventilator device is a manualresuscitator device.

In one embodiment of the method, the endotracheal tube is disposedwithin a patient, and a lung recruitment of the patient is maintainedfrom before the moving to after the moving.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIG. 1 is the ventilator adaptor with an endotracheal tube.

FIG. 2 is a ventilator adaptor having rotatable elements.

FIG. 3A is a cross-section view of a ventilator adaptor having inletsand an outlet at angles, and an annular collar.

FIG. 3B is the exterior view of the ventilator adaptor of FIG. 3A.

FIG. 4A is a top view of a rotatable ventilator adaptor in a firstposition.

FIG. 4B is a top view of the rotatable ventilator adaptor in anintermediary position.

FIG. 4C is a top view of the rotatable ventilator adaptor in a secondposition.

FIG. 5A is a slidable ventilator adaptor in a second position.

FIG. 5B is a side view of the slidable ventilator adaptor of FIG. 5A.

FIG. 6 is a slidable ventilator adaptor having a third inlet.

FIG. 7A is a bottom view of a slidable ventilator adaptor in a firstposition.

FIG. 7B is a bottom view of the slidable ventilator adaptor in anintermediary position having simultaneous fluid communication among theinlets and the outlet.

FIG. 7C is a bottom view of the slidable ventilator adaptor in a secondposition.

FIG. 8 shows a ventilation assembly (with a manual resuscitator) beingused with ventilator devices and having an endotracheal tube insertedinto a patient.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the present disclosure will now be described more fullyhereinafter with reference to the accompanying drawings, in which some,but not all embodiments of the disclosure are shown. As used herein, thewords “a” and “an” and the like carry the meaning of “one or more.”Within the description of this disclosure, where a numerical limit orrange is stated, the endpoints are included unless stated otherwise.Also, all values and subranges within a numerical limit or range arespecifically included as if explicitly written out. For convenience ofdescription, directional terms such as “down,” “horizontally,”“vertically,” etc. refer to the orientation of the ventilator adaptor asdepicted in FIG. 1 . Also, the term “inlets” refers to both the firstinlet and the second inlet.

According to a first aspect, the present disclosure relates to aventilator adaptor 10, comprising a first movable element 18 having afirst inlet 12 and a second inlet 14, and a second movable element 20movably attached to the first movable element 18 and having an outlet 16extending in a generally opposite direction from the first movableelement 18. An example ventilator adaptor 10 is shown in FIG. 1 .Preferably, a bottom surface of the first movable element 64 (i.e.,inlet junction) and the top of the second movable element 98 (i.e.,outlet junction) are proximal to each other and substantially planar,where the term “substantially planar” refers to height variations alongany given section (e.g., sections of about 10 mm in diameter or less) ofthe surface, excluding the structure of the inlets and outlet, beingreduced to about 3 mm or less. The inlet junction 64 may also be thoughtof as the contact surface of the first movable element 18, with theoutlet junction 98 being the surface of the second movable elementdirectly facing it. In one embodiment, the inlet junction 64 and theoutlet junction 98 are substantially planar and substantially parallel,wherein two lines, one normal to the inlet junction, and the othernormal to the outlet junction, would together form an angle of 0°-3°,preferably 0°-2°, more preferably 0°-1°, where an angle of 0° denotesexactly parallel inlet and outlet junctions. In another embodiment, theinlet junction 64 and the outlet junction 98 are parabolic or concave.The inlet junction 64 and the outlet junction 98 may be in contact witheach other, or spaced by a gap 44 of 0.2-2 mm, preferably 0.4-1.5 mm,more preferably 0.5-1.1 mm. FIG. 2 shows a cross-section view of aventilator adaptor 10 with such a gap 44, while FIGS. 3A and 5B showcross-section views of a ventilator adaptor 10 where the inlet junction64 and outlet junction 98 are in direct contact with each other withouta gap. As defined here, the outlet 16 extending in a generally oppositedirection from the first moveable element 18 means that the outlet 16extends away from the inlet junction 64.

In one embodiment, the ventilator adaptor 10 may comprise polypropylene,polyethylene, polymethylmethacrylate, polyether ether ketone,polycarbonate, stainless steel, titanium, titanium alloy, carbon fiber,polytetrafluoroethylene (PTFE), ultra-high-molecular-weight polyethylene(UHMWPE), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA),polyethylene terephthalate (PET), acrylonitrile butadiene styrene (ABS),polytetrafluoroethylene (PTFE), glass, ceramic, or some otherbiocompatible material. In one embodiment, the ventilator adaptor 10 maybe intended for single use. In a further embodiment, a ventilatoradaptor 10 intended for single use may be sterilized, for example, bygamma ray radiation or ethylene oxide exposure, and may be packagedseparately in sterile packaging. In another embodiment, the ventilatoradaptor 10 may comprise stainless steel or a heat-resistant plastic, andmay be autoclaved between multiple uses. The ventilator adaptor 10 mayhave sidewall thicknesses of 0.5-4.0 mm, preferably 0.6-3.0 mm, morepreferably 0.7-1.5 mm.

In one embodiment, a movable compression seal is sandwiched between thefirst movable element 18 and the second movable element 20. Forinstance, this seal may be an O-ring 40 fit into a groove in the inletjunction 64 or the outlet junction 98. The seal may comprise anelastomeric material, such as silicone rubber, latex, butyl rubber,neoprene, and/or nitrile. Preferably the seal is made of a material thatcan be compressed and moved across a surface, without degrading orlosing its pressure resistance. The seal may be located along aperimeter of either of the inlets or the outlet. In a furtherembodiment, a second seal may be located along a perimeter of either theinlet junction or the outlet junction and encircle or contain bothinlets. FIGS. 2 and 3A show cross-section views of a ventilator adaptor10 with O-rings 40.

In one embodiment, the outlet 16 has an inner diameter of 14.0-16.0 mm,14.5-15.5 mm, or preferably about 15 mm, and an outer diameter of 16-26mm, preferably 18-24 mm, more preferably 20-23 mm. The first inlet 12and the second inlet 14 (“inlets”) each have an outer diameter of14.0-16.0 mm, preferably 14.5-15.5 mm, or about 15 mm, and an innerdiameter of 5.0-15.5 mm, preferably 10.0-14.7 mm, more preferably12.0-14.5 mm. In a preferred embodiment, the inlets 12/14 and the outlet16 are shaped to accept standard respirator fittings, with the inletshaving outer diameters of about 15 mm, and the outlet having an innerdiameter of about 15 mm. The ventilator adaptor 10 may have a similarappearance and size as a heat moisture exchanger (HME). In oneembodiment, the inlets 12/14 are 15 mm M connectors (also known as 15Mconnectors), and the outlet 16 is a 22 mm M/15 mm F connector (alsoknown as a 22M/15F connector). These connectors may allow respiratory orventilator devices to connect to the ventilator adaptor 10 by frictionalcoupling. These devices may connect directly to the ventilator adaptor10 or through a length of tubing, for example, 0.3-2.0 m long, or1.0-1.5 m long. Examples of respiratory or ventilator devices include,but are not limited to, a manual resuscitator device 86 (also known as aresuscitator bag), an automatic resuscitator, a gas tank, and amechanical ventilator 84 (including transport ventilators,intensive-care ventilators, and neonatal ventilators).

In one embodiment, either of the inlets 12/14 or the outlet 16 may beremovably attached to the first movable element 18 or the second movableelement 20, for instance, through frictional coupling, screw threads, ora bayonet mount.

In an alternative embodiment, other standardized respirator connectorsmay be used such as 22M, 22F, a Luer lock, a 30 mm outlet, a 7.6 mmport, or an 8 mm spigot. In another alternative embodiment, attachmentsto either of the inlets 12/14 or the outlet 16 on the ventilator adaptor10 may be possible with screw thread connectors, clips, clamps, magnets,ties, bands, or clasps.

In one embodiment, the ventilator adaptor 10 has a third inlet 62 on thefirst movable element 18 or a second outlet 46 on the second movableelement 20. For example, FIG. 6 shows a ventilator adaptor 10 with athird inlet 62 on the first movable element 18, and FIG. 2 shows aventilator adaptor 10 with a second outlet 46 on the second movableelement 20. In another embodiment, the ventilator adaptor 10, which,other than the first inlet 12, the second inlet 14, and the outlet 16,does not have an additional inlet or outlet, such as the ventilatoradaptor 10 shown in FIGS. 1, 3A, 3B, and 5A.

The inlets 12/14 and the outlet 16 may be cylindrically shaped withlengths of 10-55 mm, preferably 12-25 mm, more preferably 15-20 mm. Inone embodiment, the first inlet 12, the second inlet 14, and/or theoutlet 16 may be in the form of right cylinders, having a central axisand sides substantially perpendicular to the inlet junction 64 or to theoutlet junction 98, and with the same cross-section area throughout thelength of the cylinder. In some embodiments, the inlets 12/14 and/or theoutlet 16 may have a length shorter than 25 mm as a connector may notneed to fit over or into an entire 25 mm or greater length. As definedhere, “substantially perpendicular” refers to two elements forming anangle of 86°-90°, preferably 87°-90°, more preferably 89°-90°, where 90°is perpendicular. These embodiments are shown in FIGS. 1, 2, 5A, 5B, and6 , which have at least one substantially perpendicular inlet 70 oroutlet 96.

In another embodiment, the first inlet 12, the second inlet 14, and/orthe outlet 16 may be in the form of a truncated cylinder, where thetruncation occurs at the attachment of the first inlet 12 and/or thesecond inlet 14 to the first movable element 18, or at the attachment ofthe outlet 16 to the second movable element 20, so that each distal edgeof the first inlet, the second inlet, and the outlet still encircles aplane perpendicular to each central axis. In other words, in thisembodiment, the first inlet 12, the second inlet 14, and/or the outlet16 has the form of a truncated cylinder with a central axis that is notsubstantially perpendicular to the inlet junction 64 or the outletjunction 98. These embodiments are shown in FIGS. 1, 3A, and 3B. In oneembodiment, a first central axis 92 of the first inlet 12, or a secondcentral axis 94 of the second inlet 14, or both forms an angle of50°-80°, preferably 55°-75°, more preferably 60°-70° with the surface ofthe inlet junction 64. In a preferred embodiment, the first central axis92 and the second central axis 94 form angles of 60°-70° with the inletjunction 64. These angles may help avoid interference betweensimultaneous connections on both inlets 12/14, while allowing smalldiameters or small horizontal dimensions of the first movable element 18and the second movable element 20.

In an alternative embodiment, the outlet 16 may be formed completelyinside the second movable element 20, for example as a hole with a depthof 10-55 mm, preferably 12-25 mm, more preferably 15-20 mm, and adiameter of 14.5-15.5 mm, preferably about 15 mm, or as a hole otherwisesized to accept a 15M fitting partially or completely inserted. Thisembodiment would require that the second movable element has a thicknessat least as large as the hole's depth.

In one embodiment, a surface of the first movable element opposite thesecond movable element is substantially planar (i.e. this surface beingthe inlet junction 64), and a section of the first inlet or the secondinlet is angled or curved, so that a distal edge 60 of the first inletor the second inlet circumscribes a plane forming an angle of 60°-90°,preferably 65°-90°, more preferably 75°-90° with the surface 64. In oneembodiment, the distal edge 60 circumscribes a circle that issubstantially perpendicular to the inlet junction 64. In theseembodiments, one or more inlets 12/14 does not extend along a linearcentral axis, but along a curved or angled path. FIGS. 5A and 6 show anangled inlet 68 and/or a curved inlet 72. In other embodiments, a singleinlet may be both curved and angled, or shaped in other means in orderthat the distal edges circumscribe planes having angles as previouslymentioned.

In one embodiment, the inlets 12/14 or the outlet 16 may not comprisethe same cross-section area or shape throughout their entire length. Forinstance, a portion of the inlets or the outlet may have more than onediameter throughout its length, or may have a continually varyingdiameter, for instance, as a conical segment. In one embodiment, one ormore inlets 12/14 or the outlet 16 may connect to the first movableelement 18 or the second movable element 20 through a segment having adiameter 20%-80% smaller, preferably 30%-70% smaller, more preferably40%-60% smaller than a portion adjacent to a distal edge. In oneembodiment, this smaller segment may have a length of 10-40 mm,preferably 15-35 mm, more preferably 18-30 mm. In a further embodiment,this smaller segment may comprise a flexible tubing material so thateither of the inlets 12/14 or the outlet 16 may be movable in differentangles while attached to the first movable element 18 or the secondmovable element 20.

In one embodiment, one or more of the inlets 12/14 or the outlet 16 hasa rotatable joint 42. This rotatable joint 42 may be at the attachmentof either of the inlets 12/14 or the outlet 16 to the first movableelement 18 or the second movable element 20, respectively, or may besomewhere along either of the inlets 12/14 or the outlets 16 at aposition between that attachment and a distal end. FIG. 2 shows inlets12/14 each having a rotatable joint 42 comprising a collar. Here, thecollar connects together two segments of each inlet 12/14 to allowrotation while preventing air leaks. In another embodiment, two segmentsmay be joined by nesting an annular flange of one segment into anannular groove of the other segment.

According to a second aspect, the present disclosure relates to aventilation assembly 100 comprising the ventilator adaptor 10 of thefirst aspect and an endotracheal tube 36 removably attached to theoutlet 16 of the ventilator adaptor. In other embodiments, differentventilation assemblies may be possible with one or more of the inlets12/14 or outlet 16 forming a permanent connection with a ventilatordevice 78/80, an endotracheal tube 36, or some accessory device. Forexample, the ventilator adaptor 10 may be formed and packaged as aventilation assembly 100 with an endotracheal tube 36 adhered to theoutlet 16. In other embodiments, the ventilator adaptor 10 may have orbe packaged as a ventilation assembly 100 with an endotracheal tube 36removably attached to the outlet 16. The endotracheal tube 36 maycomprise a tubing with a smaller diameter connected to a barbed fittingof an adaptor 38 having a distal 15M fitting configured to fit into theoutlet 16 having a 22M/15F connector. FIGS. 1 and 8 show ventilationassemblies 100 comprising ventilator adaptor 10 and endotracheal tubes36. Alternative ventilation assemblies may be possible with one or moreaccessory devices, such as those previously mentioned. One or moreaccessory devices may be removably or permanently attached to aventilator adaptor 10 at one or more of the inlets 12/14 or outlet 16,or at some other location on the ventilator adaptor 10.

An endotracheal tube 36 is a type of catheter inserted into the tracheathrough the mouth (orotracheal) or nose (nasotracheal) of a patient forthe primary purpose of establishing and maintaining a clear airway andto also ensure an adequate exchange of oxygen and carbon dioxide.Endotracheal tubes 36 may be used to deliver oxygen in higherconcentrations than found in air, or to administer other gases such ashelium, nitric oxide, nitrous oxide, xenon, or certain volatileanesthetic agents such as desflurane, isoflurane, or sevoflurane.Endotracheal tubes 36 may also be used as a route for administration ofcertain medications including, but not limited to, salbutamol, atropine,epinephrine, ipratropium, and lidocaine, in vaporous or aerosol(droplet) states. Endotracheal tubes 36 are commonly used for airwaymanagement in the settings of general anesthesia, critical care,mechanical ventilation, and emergency medicine.

Endotracheal tubes 36 may be constructed of or comprise polyvinylchloride, silicone rubber, latex rubber, stainless steel or otherbiocompatible material. Most endotracheal tubes 36 have an inflatablecuff to seal the trachea and bronchial tree against air leakage andaspiration of gastric contents, blood, secretions, and other fluids.Alternatively, endotracheal tubes 36 may be uncuffed, especially forpediatric patients. Endotracheal tubes 36 may be configured for oral ornasal entry, may be preformed, reinforced with a metal wire or otherrigid material, labeled with a contrast agent or radio opaque material,or may be configured as double-lumen endobronchial tubes, which allowsingle-lung ventilation while one lung is collapsed for a surgicalprocedure. Endotracheal tubes 36 may also have a beveled tip, anadditional hole at the tip (called a “Murphy eye”) to prevent blockage,and/or length markings. Endotracheal tubes 36, such as RAE tubes, mayhave preformed curves in order to be used in south facing or northfacing insertion.

For human patients, endotracheal tubes 36 range in size from 2-10.5 mmin inner diameter, with adult patients generally using tubes with innerdiameters of 6.5-9.5 mm, preferably 7.0-9.0 mm. Endotracheal tubes 36for human patients may have wall thicknesses of 0.7-1.8 mm, preferably0.8-1.7 mm, more preferably 0.9-1.3 mm, and may have lengths orinsertion depths of 5-30 cm, preferably 15-27 cm, more preferably 20-24cm. Endotracheal tubes larger than 6 mm inner diameter usually have aninflatable cuff. Another type of endotracheal tube 36 has an openingabove the inflatable cuff, which can be used for suction of thenasopharngeal area, which helps reduce the risk of chest infections inlong-term intubated patients.

In alternative embodiments, where maintaining lung recruitment may notbe a goal, a respirator or resuscitation mask may be attached to theoutlet 16 and may be configured to cover the nose and/or mouth of apatient. In additional alternative embodiments, a nasal cannula, atracheotomy or tracheostomy tube, a tracheal tube introducer (a“bougie”), or a tracheal button may be attached to the outlet 16. In analternative embodiment, the outlet may be attached to a chamber, such asa glove box, a hyperbaric chamber or oxygen tent, a hypobaric chamber, adecompression chamber, or a recompression chamber.

As mentioned previously, an accessory device may attach to one or moreof the inlets 12/14 or the outlet 16. A ventilator adaptor 10 with anaccessory device permanently or removably attached may be considered asan alternative type of a ventilation assembly. Alternatively, anaccessory device may attach elsewhere on the ventilator adaptor 10, suchas through the first movable element 18 or an access port, and havefluid communication with one or more of the inlets 12/14 or the outlet16. The accessory device may be an inline manometer, a filter, a one-wayvalve such as a positive end expiratory pressure (PEEP) valve, athermometer, a hygrometer, a flow meter, a syringe, or an access port.An access port may be used for a catheter, a suction device, or as ameans of administering vaporous or liquid medicines to a patient. Anaccess port may also be used to insert a camera to allow visualexamination of the respiratory tract.

In one preferred embodiment, the ventilator adaptor 10 has no air leak.However, in an alternative embodiment, the ventilator adaptor 10 mayhave a leak rate of less than 25 mL/min, preferably less than 15 mL/min,more preferably less than 10 mL/min. In one embodiment, the ventilatoradaptor 10 may be able to withstand interior pressures of 16 kPa orless, preferably 14 kPa or less, more preferably 12 kPa or less.Generally, mechanical ventilators are provided with safety mechanisms toprevent high airway pressure. However in an alternative embodiment, theventilator adaptor 10 may be designed with an additional valve thatopens to relieve a higher pressure, or a valve that is always open torelieve some amount of pressure continually. Such an additional valvemay ensure that a continuous positive pressure is applied to a patient88. In one embodiment, the ventilator adaptor may handle flow rates thatcreate the previously mentioned pressures, or flow rates of up to 60L/min, preferably up to 40 L/min, more preferably up to 30 L/min.Preferably, the ventilator adaptor is able to handle inspiratory flowrates of about 40-60 L/min, though for some patients, the inspiratoryflow rate may be above or below that range. Preferably, the ventilatoradaptor is able to handle expiratory flow rates of up to 100 L/min,though for some patients, the expiratory flow rate may be greater than100 L/min.

In one embodiment, the ventilator adaptor 10 has a cap 22 configured tocover the first inlet 12, the second inlet 14, or both independently.This cap 22 may have similar inner and outer diameters as mentionedpreviously for the outlet 16, and may have a depth of 5-20 mm,preferably 7-15 mm, more preferably 8-10 mm. Preferably the cap 22 cansecure to and cover the distal edge of one or more inlet 12/14 by meansof frictional coupling, though in an alternative embodiment, the cap 16may fit by means of a screw thread or some other structure. Preferablythe cap 16 is able to cover an inlet, in order to keep the inlet cleanand/or sterile. For instance, the cap 16 may not need to stay secureagainst pressure differences, as it may be intended to only cover aninlet not actively engaged in ventilation. However, in an alternativeembodiment, cap 16 may stay secured against differences in pressure, forinstance, being able to withstand pressure differences of up to 5.0 kPa,preferably up to 4.0 kPa, more preferably up to 3.0 kPa. The cap 16 maycomprise materials previously mentioned for the ventilator adaptor 10,and/or elastomeric materials such as those listed for the compressibleseal 40. Preferably the cap 16 comprises silicone or rubber in order toassist in both fitting and sealing of the cap to the inlet. In oneembodiment, the cap 16 comprises a tether 24 to connect with the rest ofthe ventilator adaptor 10. This tether 24 may be a strip of materialsuch as those previously mentioned for the ventilator adaptor 10 orcompressible seal 40, and may have a width of 2-10 mm, preferably 2.5-9mm, more preferably 3-8 mm, and a length of 5-20 cm, preferably 5-15 cm,more preferably 5-8 cm. The tether 24 may be connected to a ringrotatably attached on a circumference of either of the inlets 12/14, orthe tether may be connected to either first 18 or second 20 movableelements, or to a connecting collar 48. In one embodiment, the tether 24is attached to a crossbar 26, and may furthermore be slidably attachedby terminating in a loop 28 that encircles a part of the crossbar 26.The crossbar 26 may be connected to the first inlet 12 and the secondinlet 14, or may be connected elsewhere, such as on the first movableelement 18. The crossbar 26 may have a length of 0.5-3 cm, preferably0.7-2.5 cm, more preferably 0.8-2.3 cm and a diameter of 0.2-3 mm,preferably 0.5-2 mm, more preferably 0.6-1.5 mm. In one embodiment,where the tether 24 is attached to a crossbar 26 connected to bothinlets 12/14, the cap 22 is able to cover both inlets 12/14independently. This configuration of the cap 22, tether 24, and crossbar26 is shown in FIG. 1 .

In an alternative embodiment, the cap 16 may be able to fit on bothinlets 12/14 and the outlet 16 independently. Where the inlets 12/14 are15M connectors, and the outlet 16 is a 22F/15M connector, the cap 16 maycomprise one or more raised concentric rings that allow it to interfacewith both types of connectors. Alternatively, one side of the cap mayfit 15M connectors, while the opposing side fits 22F/15M connectors. Inanother alternative embodiment, an elongated cap 22 may be able to coverboth inlets 12/14 simultaneously. In another embodiment, a cap 22 maycomprise an additional adaptor or an access port.

As mentioned previously, the first movable element 18 and the secondmovable element 20 are movably attached to each other. The outlet 16 isin fluid communication with the first inlet 12 in a first position 52 oris in fluid communication with the second inlet 14 in a second position56 by moving the second movable element 20 relative to the first movableelement 18 (or vice versa) thereby aligning the outlet 16 with the firstinlet 12 or the second inlet 14. Furthermore, the outlet in the firstposition 52 has no fluid communication with the second inlet 14, and theoutlet in the second position 56 has no fluid communication with thefirst inlet 12. This moving may be performed by sliding or rotating thefirst movable element 18 relative to the second movable element 20. Inan alternative embodiment, the moving may involve both sliding androtating, for example, where the moving engages or disengages a lock. Inanother alternative embodiment, the moving may involve other movementssuch as tilting, pressing, or pulling the first movable element 18relative to the second movable element 20.

In one embodiment, the first movable element 18 has a third inlet 62,and a third position is possible which aligns the outlet 16 with thethird inlet 62, establishing fluid communication between the outlet 16and the third inlet 62.

In one embodiment, an intermediary position 76 of the outlet 16 betweenthe first position 52 and the second position 56 establishes fluidcommunication simultaneously among the first inlet 12, the second inlet14, and the outlet 16. An example of this is shown in FIG. 7B, which isan intermediary position 76 of the outlet 16 between the first position52 in FIG. 7A and the second position 56 in FIG. 7C. FIG. 7B shows thatthe outlet 16 opens to portions of both inlets 12/14 at the same time,which thus establishes fluid communication among both inlets 12/14 andthe outlet 16. However, depending on the spacing of the inlets 12/14relative to the range of the outlet's movement, a ventilator adaptor 10that has an outlet intermediary position that simultaneously establishesfluid communication among the inlets and the outlet may have additionalintermediary positions that do not establish such fluid communication.For instance, the first 18 and second 20 movable elements may be movedone way through an intermediary position 76 with the simultaneous fluidcommunication, but moved another way without encountering suchintermediary position. This movement may occur when the first 18 andsecond 20 movable elements are rotated in different directions, as theoutlet 18 may encounter different circumferential spacing between inlets12/14 if the inlets are not arranged with two-fold rotation symmetry.

In one embodiment, one or more of the inlets 12/14 or the outlet 16 mayhave a valve to limit or completely shut off the flow of air. In onealternative embodiment, where an intermediary position 76 is possiblefor simultaneous fluid communication among the inlets 12/14 and theoutlet 16, a ventilator adaptor 10 having valves in both inlets 12/14may not need to have movable elements, as the flow path may bedetermined by independently operating those valves. This way, a firstposition 52 and second position 56 of the outlet 16 may be achievedwithout having to move first 18 and second 20 movable elements relativeto each other. In this alternative embodiment, the ventilator adaptor 10may be formed as a Y-shape.

In one embodiment, a ventilator adaptor 10 may have no intermediaryposition of the outlet between the first position 18 and the secondposition 20 that establishes fluid communication simultaneously amongthe first inlet 12, the second inlet 14, and the outlet 16. Again, thischaracteristic depends on the spacing of the inlets relative to therange of the outlet's movement. FIGS. 4A and 4C show first 52 and second56 positions of the outlet, respectively. Here, no intermediarypositions are able to establish fluid communication simultaneously amongthe inlets 12/14 and the outlet 16. An example intermediary position 54which does not allow fluid communication between the outlet 16 and bothinlets 12/14 is shown in FIG. 4B. Preferably, this intermediary position54 exists only because of design choices in the ventilator adaptor 10,as the position is experienced only transiently while someone is quicklyswitching between first 52 and second 56 positions. Preferably, apatient having maintained lung recruitment using the ventilator adaptor10 with ventilators may not experience this intermediary position forlonger than 5 seconds. However, in an alternative embodiment, such anintermediary position may be used intentionally to prevent fluidcommunication to the outlet 16, essentially closing the ventilatoradaptor 10.

In one embodiment, the ventilator adaptor 10 has a switch 30 to lock thefirst movable element 18 relative to the second movable element 20. Theswitch may be used to lock the outlet 16 in the first position 52 or thesecond position 56. Locking the outlet in either position may preventaccidental movement of the outlet when being used in a ventilatorcircuit. In one embodiment, the switch 30 may be a sliding panel havinglengths and widths of about 0.5-2.5 cm, preferably 0.8-2.1 cm, morepreferably 0.8-1.2 cm. The switch 30, as a sliding panel, may be held orsecured in grooves within the first movable element 18 or the secondmovable element 20, and a portion may be moved into a complementarynotch 32 or slot in order to prevent movement of the other movableelement. FIG. 1 shows such a switch 30, which here is in an unlockedposition. The exterior surface of the switch 30 may be pattered withgrooves, ribs, knurls, or some other texture in order to facilitate afinger grip. Other types of switches 30 may be configured to lock theoutlet 16 in the first position 52 or the second position 56. Forexample, a switch may comprise an axle with a cam housed in one movableelement. Rotating the axle by an exterior knob may insert the cam into aslot in the opposing movable element, or the cam may slide a piston intothe opposing movable element. In other embodiments, locking the outlet16 in the first position 52 or the second position 56 may be possible bypressing the outlet 16 partially into the first movable element 18, orthe first 18 or second 20 movable elements may have clamps, clips, orsome similar structure to allow a user to temporarily limit movement.

In one embodiment, the ventilator adaptor 10 has a label, a notch, or agroove to indicate an alignment of the first movable element 18 relativeto the second movable element 20. One or more of a label, notch, orgroove may indicate an alignment that places the outlet 16 in the firstposition 52, the second position 56, or an intermediary position 54/76.For instance, one or both movable elements 18/20 may have lines, arrows,arrowheads, or shapes that can align and indicate the relative positionsof the first movable element 18 to the second movable element 20 thatplace the outlet 16 in the first position 52 or second position 56. FIG.1 shows a ventilator adaptor 10 with arrowheads 34. Labels on eithermovable element 18/20 may be textured, raised, depressed, or flush withthe exterior surface of the movable element. In an alternativeembodiment, a ventilator adaptor 10 may use electronic circuitry withone or more LED indicator lights to indicate the outlet 16 in the firstposition 52, a second position 56, or an intermediary position 54/76.

Depending on the structure of the switch 30, an additional label, notch,or groove may not be necessary. For instance, where the switch 30 is asliding panel that slides into a notch 32, such as in FIG. 1 , eithermovable element would have at least two notches, which may besufficiently visible to indicate the outlet 16 being in the first 52 orsecond position 56.

In one embodiment, a ventilator adaptor 10 with rotatable first 18 andsecond 20 movable elements may not be shaped as a disc but instead as adifferent shape having two-fold rotational symmetry, such as ageneralized cylinder having an elliptical base or a rectangular prismhaving a non-square base. In this embodiment, a label, notch, groove, orother marking may not be needed to designate when a 180° rotation isachieved, as it would be easily evident by the shape of the movableelements. Preferably, in this embodiment, the ventilator adaptor is ableto maintain a closed ventilation system while the first 18 and second 20movable elements are being rotated.

In one embodiment, the first movable element 18 is slidable relative tothe second movable element 20 to align the outlet 16 with the firstinlet 12 in the first position 52 or the second inlet 14 in the secondposition 56. These embodiments are illustrated in FIGS. 5A, 5B, 6, and7A-7C. In FIGS. 5B and 7A-7C, the second movable element 20 is a flatpanel to which the outlet 16 is connected. Two opposing edges of thepanel are shaped to fit into the two grooves made by the linearinwardly-directed lip 58 of the first movable element 18. Here, thesecond movable element 20 may be moved by putting force on either sideof the outlet 16, though in a related embodiment, the second movableelement 20 may have a tab or some other structure for a user to handledirectly. In another embodiment, the movable elements 18/20 may bespring-loaded, so that force is required to compress or stretch a springin one direction, while the spring relieves force in the otherdirection. In one embodiment, as shown in FIGS. 7A-7B, bars 74 on thefirst movable element 18 may connect the bottom edges 58, while goingunderneath the second movable element 20. These bars 74 may be placed tobe adjacent to one side of the outlet 16 in either first position 52 orsecond position 56. These bars 74 may allow proper alignment of thesecond movable element 20, as a user may slide the second movableelement 20 until a bar 74 contacts the outlet 16, which would preventfurther sliding movement. Alternatively, a raised structure attached tothe underside of the second movable element may be used to contact thebar 74, rather than the outlet 16 itself. In alternative embodiments,the ventilator adaptor 10 may comprise or be attached to tracks, rails,gears, ball bearings, wheels, or other mechanical structures to assistin a controlled sliding movement.

In one embodiment, the first movable element 18 is rotatable relative tothe second movable element 20 to align the outlet 16 with the firstinlet 12 in the first position 52 or the second inlet 14 in the secondposition 56. The movable elements 18/20 may be rotated in a right orleft-handed direction, though in one embodiment, the ventilator adaptor10 may have a ratchet to only allow rotation in one direction. Inanother embodiment, either or both movable elements 18/20 may bestructured with an additional groove or channel that limits the maximumrotation to a certain number of degrees, for instance, to a 178°-182°maximum rotation, or a 118°-122° maximum rotation.

In a further embodiment, where the first 18 and second 20 movableelements are rotatable relative to each other, the first movable element18 and the second movable element 20 are disc-shaped, and either or bothmay have thicknesses of 0.6-2.6 cm, preferably 0.8-2.0 cm, morepreferably 0.9-1.5 cm and diameters of 4.0-10 cm, preferably 4.5-8 cm,more preferably 4.8-6 cm. As mentioned previously, in one embodiment,where the first movable element 18 and the second movable element 20 arerotatable relative to each other, the first and/or second movableelements may have other shapes such as a generalized cylinder having anelliptical base or a rectangular prism having a non-square base, inorder to identify rotation positions. In other embodiments, the first 18and second 20 movable elements may meet with circular faces, but withopposing sides being curved, for example, where either or both elementsmay have spherical curves (such as a spherical cap or sphericalsegment). In other embodiments, either or both movable elements 18/20may have angled edges, or a combination of angular, flat, and/or curvedsurfaces. In one embodiment, where the inlets 12/14 are angled away fromeach other, the outer surface of the inlets may be merged together andformed with the first movable element 18. In a further embodiment, wherethe outer surfaces of the inlets are merged together, the top 66 of thefirst movable element may have no surface substantially parallel to theinlet junction 64.

FIGS. 1, 2, 3A, 3B, and 4A-4C show ventilator adaptors 10 where thefirst 18 and second 20 movable elements are rotatable relative to eachother. In these figures, the first 18 and second 20 movable elements arefurthermore disc-shaped. Rotatable first 18 and second 20 movableelements may be attached by means of one movable element having anannular inwardly directed radial lip, which surrounds a circumference ofthe other movable element. For example, FIGS. 4A-4C show an annularinwardly directed radial lip 50 of the second movable elementsurrounding a circumference of the top of the first movable element 66.Alternatively, the lip may be a part of the first movable element, ormay comprise a series of inwardly directed tabs, rather than acontinuous lip. In another embodiment, an annular collar 48 may fit intoannular grooves on both first 18 and second 20 movable elements, asshown in FIGS. 3A and 3B, which annular collar holds the movableelements together while allowing rotatable motion. In one embodiment,the movable elements may comprise a rounded bead and an annular groovethat may be rotatable, and also removably attached, similar to a lid ona disposable coffee cup. In another embodiment, rotatable first 18 andsecond 20 movable elements may be attached through a central axle.Rotatable first 18 and second 20 movable elements may comprise or beattached to tracks, rails, gears, ball bearings, wheels, or othermechanical structures to assist in controlled movement.

According to a third aspect, the present disclosure relates to a methodfor switching between ventilator devices 78/80 with the ventilationassembly 100 of the second aspect, while maintaining respiratory supportthrough the endotracheal tube 36. This method involves providingrespiratory support by fluidly connecting the endotracheal tube 36 witha first ventilator device 78 fluidly connected to the first inlet 12,wherein the outlet 16 is in the first position 52; connecting a secondventilator device 80 to the second inlet 14; moving the outlet 16 fromthe first position 52 to the second position 56, thereby providingrespiratory support by fluidly connecting the endotracheal tube 36 withthe second ventilator device 80; and disconnecting the first ventilatordevice 78 from the first inlet 12.

In one embodiment of the method, the first ventilator device 78 is amechanical ventilator 84, and the second ventilator device 80 is amanual resuscitator device 86. FIG. 8 shows this embodiment, whereventilator devices 78/80 have 22F connectors 82 to connect with theventilator adaptor 10. Following the method as described earlier, themechanical ventilator 84 is attached to the ventilation assembly 100 andprovides respiratory support. The manual resuscitator device 86 isattached to the ventilator adaptor 10 by movement A. The outlet isswitched between first and second positions by rotation as shown in B.The mechanical ventilator 84 may then be detached by movement C.

However, in a related embodiment, the first ventilator device 78 is amanual resuscitator device 86, and the second ventilator device 80 is amechanical ventilator 84. In other related embodiments, differentcombinations and types of ventilator devices, such as those previouslymentioned, may be attached to the ventilator adaptor 10 for the purposeof switching between ventilator devices. In another embodiment, first 78and second 80 ventilator devices may be left attached to the inlets12/14 with no disconnecting, and in a further embodiment of this, theoutlet 16 may be moved back and forth between second 56 and first 52positions as needed.

In one embodiment of the method, the endotracheal tube 36 is disposedwithin a patient 88, as shown in FIG. 8 , and a lung recruitment of thepatient 88 is maintained from before the moving to after the moving.Here, the ventilator adaptor 10 is able to switch between operatingventilator devices 78/80 without interruption to the patient 88, whileproviding respiratory support. Preferably this switching is done withina short time interval, for example, of less than 1.5 seconds, preferablyless than 1 second, more preferably less than 0.8 seconds in order tomaintain respiratory support through the outlet 16. However, inembodiments where intermediary positions 76 of the outlet 16 allowsimultaneous fluid communication among inlets 12/14 and outlet 16, suchas that discussed with FIG. 7B, it may be possible to switch betweenventilator devices 78/80 more slowly than 1.5 seconds while providingrespiratory support through the outlet 16. Preferably the switching isdone by a medical professional, though a patient 88 using a ventilatorat home may be able to use the ventilator adaptor 10 to switchventilator devices by his or herself, or have a caregiver do so.Preferably, throughout the method of switching, the respiratory supportis maintained as a closed system, which reduces the risk of ventilatorassociated pneumonia (VAP). By reducing the risk of VAP, the totalintensive care unit and hospital stay cost may be reduced. In anotheralternative embodiment, the ventilator adaptor 10 may be housed in amachine or may have mechanical elements to move the outlet 16 from thefirst position 52 to the second position 56. In this embodiment, aperson does not need to directly handle the ventilator adaptor 10.

As defined here, “providing respiratory support,” means that anunimpeded flow of air is delivered to one or both lungs 90 of a patient88. As mentioned previously, this includes air enriched in oxygen, orair mixed with water vapor or vaporous medicines. “Providing respiratorysupport” is analogous to maintaining or providing lung recruitment of apatient 88, meaning that the lung 90 does not collapse, and thatrespiratory failure is prevented.

In a preferred embodiment, the patient 88 is a human, but in otherembodiments, the patient 88 may be a non-human mammal, including, butnot limited to, dogs, cats, horses, and elephants.

1. A ventilation assembly, comprising: an endotracheal tube, arespiratory device selected from the group consisting of a resuscitatorbag, an automatic resuscitator and a gas tank, a mechanical ventilatorselected from the group consisting of a transport ventilator, anintensive-care ventilator and a neonatal ventilator, and a ventilatoradaptor, comprising: a first movable element having a first inlet and asecond inlet on an outer surface, wherein the first movable element hasa concave inner surface opposite the outer surface; and a second movableelement movably attached to the first movable element and having anoutlet tube extending in an opposite direction from the first movableelement, wherein the second movable element has an outer surfaceopposite the outlet tube matching the concave inner surface of the firstmovable element, wherein the inner surface of the first movable elementincludes circumferential grooves surrounding the first inlet and thesecond inlet, each groove configured to hold an o-ring in compressionbetween the inner surface of the first movable element and the outersurface of the second movable element and separate the inner surface ofthe first movable element and the outer surface of the second movableelement by a gap of 0.2-2 mm, wherein the first movable element has anintegral annular inwardly directed radial lip that fits into an annularradial groove around the circumference of the second movable element,wherein the outlet tube has an inner diameter of 14.5-15.5 mm, whereinthe first inlet and the second inlet have an outer diameter of 14.5-15.5mm, and whereby the outlet tube is in fluid communication with the firstinlet in a first position or is in fluid communication with the secondinlet in a second position by moving the second movable element relativeto the first movable element thereby aligning the outlet tube with thefirst inlet or the second inlet, wherein the endotracheal tube isremovably attached to the outlet tube, and wherein the first movableelement is rotatable relative to the second movable element to align theoutlet tube with the first inlet in the first position or the secondinlet in the second position, wherein the respiratory device is attachedto the first inlet and the manual resuscitator device is attached to thesecond inlet.
 2. (canceled)
 3. The ventilation assembly of claim 1,wherein a first central axis of the first inlet, a second central axisof the second inlet, or both forms an angle of 50°-80° with the surface.4-6. (canceled)
 7. The ventilation assembly of claim 1, which, otherthan the first inlet, the second inlet, and the outlet tube, does nothave an additional inlet or outlet. 8-15. (canceled)
 16. The ventilationassembly of claim 1, further comprising a label, a notch, or a groove toindicate an alignment of the first movable element with respect to thesecond movable element in the first position or in the second position.17-20. (canceled)
 21. The ventilation assembly of claim 1, wherein nocollar is present around the circumference of the first or secondmovable element.